FDA Inspection 836363 — Delsys, Incorporated
The FDA completed an inspection of Delsys, Incorporated on June 18, 2013 in Natick, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 18, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Natick, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2338 | 21 CFR 820.22 | Quality audit - audit report review |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |